RecruitingPhase 2NCT06954597

Safety and Tolerability of TOP-N53 Applied on Digital Ulcers in Patients With Systemic Sclerosis

Local and Systemic Safety and Tolerability of Ascending Doses of TOP-N53, a Nitric Oxide (NO)-Releasing Phosphodiesterase-5 (PDE5) Inhibitor, Administered Topically, on Wounds in Patients With Digital Ulcers (DU) in Systemic Sclerosis (SSc) in an Open-label, Vehicle-controlled, Phase 2a, Multi-center Clinical Trial


Sponsor

Topadur Pharma AG

Enrollment

15 participants

Start Date

Feb 4, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The main goal of this clinical trial is to learn about how safe the new drug TOP-N53 solution is when it is applied to open wounds on the fingertip (digital ulcers) in people with an uncommon illness that results in hard, thickened areas of skin and additional problems with internal organs and blood vessels (systemic sclerosis). Another goal is to learn if different strengths of TOP-N53 can treat certain aspects of the illness. Men and women between 18 and 69 years of age with this illness may participate in the clinical trial. A parallel treatment with Sildenafil 20 mg is allowed for clinical trial participants. The main questions the clinical trial aims to answer are: * Does TOP-N53 cause medical problems at the fingertip wound after it is directly applied to the wound? * Does TOP-N53 affect certain aspects of the illness like blood flow in the fingertip wounds, itch, pain, redness, bruises and bleeding at or beyond the fingertip wounds? Researchers will compare TOP-N53 solution in different strengths to a placebo (a look-alike substance that contains no drug) to see if TOP-N53 works to affect the aspects of the illness listed above. Participants will receive one or two treatments with the placebo or different strengths of TOP-N53. The higher strength of the drug will only be given to participants after the lower strength was found to be safe. Participants will visit the clinic up to 8 times within a maximum of 31 days. 2 visits may be done by telephone. The doctors will ask questions to ensure that it is safe for the participants to be in the clinical trial, apply the drug and follow-up on any medical problem after the treatment. They will also test if the drug works to treat the illness by several test methods before and after the treatment. Participants will help to find out whether the drug works to treat the illness and is safe by answering questions in a diary at different timepoints before and after treatment.


Eligibility

Min Age: 18 YearsMax Age: 69 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new topical treatment called TOP-N53 applied directly to painful finger ulcers (sores) in people with systemic sclerosis (SSc), also known as scleroderma. Scleroderma is an autoimmune disease that can restrict blood flow to the fingers, causing painful open wounds. Researchers want to see if TOP-N53 is safe and how well the body tolerates it. **You may be eligible if...** - You are between 18 and 69 years old with a confirmed diagnosis of systemic sclerosis (scleroderma) - You have at least one active finger ulcer (at least 3 mm in diameter, involving the skin layer, located at a fingertip) - You are either on a stable dose of sildenafil (a blood vessel relaxing drug) or have not taken any similar drugs for at least 4 weeks **You may NOT be eligible if...** - You have another major illness that the investigator believes would interfere with the study - Your other medications (such as endothelin receptor antagonists or calcium channel blockers) have not been at a stable dose for at least 2 weeks Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGTOP-N53

TOP-N53 solution (IMP) containing 80 µg/ml TOP-N53 is applied topically directly to the digital ulcer of patients with systemic sclerosis. The dose if defined by volume and exposure time of the IMP.

DRUGSildenafil

Parallel treatment with Sildenafil 20 mg 3-times per day is permitted if patient has been on a stable dose for 2 weeks prior to screening.

DRUGTOP-N53 vehicle

TOP-N53 vehicle solution will be topically applied to digital ulcers of systemic sclerosis patients.


Locations(5)

Centre Hospitalier Universitaire de Bordeaux, Service de Rhumatologie

Bordeaux, France

CHU Grenoble Alpes

La Tronche, France

CHRU Lille, Hôpital Claude Huriez, Rue Michel Polonosvski

Lille, France

AP-HP Hôpital Cochin

Paris, France

Reha Rheinfelden, Salinenstrasse 98

Rheinfelden, Canton of Aargau, Switzerland

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06954597